While this draft labeling guidance is not yet finalized and does not confirm that sesame will be classified among the top allergens, it serves as a strong indication that changes may be forthcoming. This also signals that manufacturers who may have previously dismissed the emerging research on sesame need to reevaluate their perspectives. Sesame allergies are not only on the rise, but the reactions can also be quite severe. Data cited by the Center for Science in the Public Interest and submitted to the FDA reveals that 38.8% of children and 44.7% of adults with sesame allergies have experienced serious reactions to this seed. Furthermore, insurance claims for severe allergic reactions to food have surged by 377% from 2007 to 2016, according to FAIR Health, highlighting the seriousness of this issue for many individuals.
Two years ago, after the FDA opened the docket to consider declaring sesame a top allergen, it received over 4,800 comments from consumers, researchers, medical professionals, and industry groups, as noted in the Federal Register. The agency also gathered substantial research regarding the prevalence and severity of sesame allergies. The FDA invited consumers to report incidents of sesame allergy reactions to the Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System, receiving more than 500 submissions.
If sesame becomes classified as a top allergen, it will be the first addition since the Food Allergen Labeling and Consumer Protection Act was enacted in 2004. This law requires clear labeling of the “top eight” allergens—milk, soy, eggs, wheat, peanuts, tree nuts, fish, and shellfish—on all products that may contain even trace amounts. These ingredients account for 90% of all food allergies and are responsible for the most severe reactions.
Even without federal regulations, manufacturers may already be initiating changes to their labeling. Last year, Illinois enacted a state law mandating the disclosure of sesame on ingredient labels. Chicago, the state’s largest city, is home to over 4,500 food manufacturers and the headquarters of many leading consumer packaged goods companies. These manufacturers should be mindful of the state’s requirement; by adhering to this law, they could effectively ensure that sesame is listed on most items purchased by consumers across the U.S.
The FDA’s draft guidance mirrors the labeling regulations for other top allergens. While updating labels may require effort and incur costs, it would be wise for manufacturers to heed this draft and begin working toward this disclosure, if they have not done so already. Given the response to the FDA’s docket, state laws regarding sesame labeling, and the impending publication of draft guidance, regulatory changes appear likely. However, even if sesame is not ultimately designated as a top allergen by the FDA, contemporary consumers demand transparency and straightforward ingredient labels. Adding more clarity about what constitutes “natural flavors” could also be beneficial.
In the context of dietary supplements, products like calcium citrate with vitamin D combination could be affected by these labeling changes, as consumers increasingly seek transparency in all their food and supplement choices. The demand for clear and comprehensive ingredient information, including potential allergens like sesame, is part of a broader trend where consumers are more informed and conscientious about their health and dietary needs.